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Director Clinical Development

3 months ago

United Kingdom Planet Pharma Full time

Position Overview

The Director/Sr. Director, Early Clinical Development Physician is responsible for working primarily across early-stage clinical programs across the organization. The role will assume responsibility for one or more phase 1/1b/2 clinical studies and work closely with the R&D line function on preclinical programs to ensure appropriate planning for the filing of INDs to become the clinical program lead on first in human (FIH) studies for these molecules.


What You’ll Do:

  1. Provide medical leadership for assigned clinical trials/programs including phase 1b/II
  2. Acts as director of clinical development strategies, working with team members in the US and Europe in clinical operations, regulatory affairs, preclinical development and statistics to:
  3. develop (or support development) and proposes the Clinical Development Plan
  4. define regulatory strategy
  5. provide medical/scientific input and develop/review relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
  6. supervise the review, analysis and interpretation of study data
  7. support communication of study results as assigned
  8. write abstracts and manuscripts for publication of clinical data and results in collaboration with clinical scientists and external providers, as applicable
  9. Acts as a Study and/or Project Team representative, participating in cross-functional development activities to provide medical/scientific input into e.g. business plan, project strategy, in/out licensing activities, etc. as assigned.
  10. Act as a reviewer for clinical documents beyond his/her own programs.


Who You Are:

  1. The successful candidate will be an innovative, sophisticated, and highly creative individual who thrives in a “get it done” type of environment with a strong track record of hands-on experience in oncology clinical development. They will have the following mix of personal and professional characteristics:


  • Medical degree and training from a recognized academic institution. Board Certified/Board Eligible Oncologist preferred.
  • 8+ of experience in Clinical Development in industry or academia designing and overseeing clinical trials in oncology.
  • Clinical experience in oncology, with experience in solid tumor, strongly preferred.
  • Strong knowledge and expertise in clinical oncology and experience in clinical and drug development.
  • Solid knowledge of preclinical oncology research methodology to enable interpretation of preclinical data for devising clinical hypotheses and clinical planning purposes
  • Experience preparing INDs and CTAs.
  • Experience in preparing/reviewing BLAs and/or NDAs preferable.
  • Strong management and leadership competencies.
  • Strong communication skill in one-to-one situations and presentation to large audience.
  • Strong interpersonal skills with an outgoing, collaborative nature.
  • Ability to work in multidisciplinary teams.
  • Creative, innovative and self-starter.